Andrew Maxwell Presents Cyban at LSI USA '23

Transcription

Andrew Maxwell  0:05  

People are dying, who don't need to. Our founder, Barry Dixon has spent his whole career treating people with traumatic brain injury and acquired brain injury in the ICU. Despite all the advances in medical care during that time, he's still shocked and and confronted by the survival statistics for people that suffer a traumatic brain injury or TBI, a 50% mortality rate, and of those that do survive 67% of long term serious disabilities. If Barry were here, he would tell you that a primary cause of poor outcomes for brain injury patients is the failure of our usual monitoring systems to detect brain hypoxia early enough to allow effective interventions and prevent permanent injury and death. He would also tell you, then is why 15 years ago, he set out on a quest to find a solution. And that is how our story at Sideman began. Would you decide to drill a hole in your patient's head and insert that Pro to measure brain oxygen? If you knew there was a better way? Would you decide to drill a hole and insert that probe? If you knew you could get equally accurate information about intracranial pressure, brain oxygen levels faster without risk to your patient and at a lower cost? The answer is simple. Of course you will. Sorry. Until now, clinicians treating unconscious inside and patients with severe brain injury have not had that choice. They've had two bad choices and inadequate hourly physical exam are an invasive, risky and expensive brain Pro. When treating TBI, the clinicians goal is to prevent brain hypoxia. That is, brain cells die within two minutes if starved of oxygen. If brain hypoxia is identified early enough, there are many interventions that clinicians can make to prevent further injury. However, in most cases, clinicians are flying by the standard of care for monitoring unconscious and sedated TBI patients is an hourly physical exam by a nurse or a clinician. A physical exam is subjective. It doesn't measure intracranial pressure or brain oxygen, it's not continuous. And as a result, brain hypoxia is often detected after damage has already occurred. In the very worst cases, a clinician may refer a patient for monitoring by invasive probe. invasive approach requires surgery, it can take hours before monitoring actually begins. And there's a 10% risk to the patient of further brain injury and a 3% chance of infection, not to mention the cost of the equipment and the surgery to implant approach. As a result, less than 20% of severe TBI patients receive invasive monitoring, and most at risk patients received no objective brain monitoring at all. clinicians want brain monitoring that allows them to minimize the likelihood of Miss judging a brain injury and to minimize the time to determine whether their treatment decisions are effective. And doing so and in doing so to do the least harm to the patients. We know that when treatment for brain Hoxie brain brain, hypoxia is guided by objective monitoring, that patient outcomes improve, and hospital costs are reduced. So let me introduce you to sidebands brain pulse monitor. Clinicians now have a solution to eradicate what we call the inflammation void, a solution that identifies complications as they happen to make faster, more relevant treatment decisions to improve patient outcomes and reduce the cost of care. Siemen's brain pulse Monitor provides easy to use non invasive measures of intracranial pressure, brain oxygen and cerebral perfusion that are continuous and accurate relative to the existing invasive gold standard. So now you know that sidebands brain pulse monitor is good for patients. It assists clinicians decision making and will reduce hospital costs. But what does that mean for our invest stunts. Well, we will launch the brain pulse monitoring the US market in q1 2024 with a CapEx consumable model where each bedside monitor will sell for $10,000. And each single use sensor set will sell for $350 on a per patient basis. By year five, we forecast installing more than 3000 bedside units that will provide sales of more than 50 million in the US market alone. Comparing to listed comps we would expect that that would create a company valued in excess of $600 million dollars. But that is only the beginning. The application of our technology provides multiple opportunities for growth over time. Our first generation product is applicable more broadly than monitoring TBI patients in the ICU. We already know our technology is applicable for acquired brain injuries such as stroke detection. We're currently trialing the brain pulse monitoring high risk cardiovascular surgery, and emergency departments. Our second generation product will target brain monitoring for first responders, neonates and military applications. And our third generation product will target other large organs where we have already collected data that shows we can measure oxygen levels non invasively in the lungs, the liver, and intestines. So what's our current status? We've published a landmark study showing our brain pulse more monitor correlates with invasive intracranial pressure monitoring. We have completed our pivotal study for FDA clearance and have met the primary endpoint expected by the FDA will publish the results of a further landmark study later this year showing our brain pulse monitor correlates with invasive oxygen probes. Our product will be equally accurate as the invasive gold standard. It will enable early interventions with lower patient risk and as you can see here, all at a lower cost to current invasive monitoring. We will have FDA clearance in calendar year 2023. And we have a clear pathway to payment as an ancillary service in the hospital setting covered under existing DRG payments for ICU and surgery procedures. We currently have boots on the ground in the US with a commercial team and advisors who have direct experience in selling into the ICU market. And we're working with clinical champions within our first four partner hospital networks. Over the coming 12 months, we are focused on delivering a portfolio of evidence generated by a US Kaos that will support our clinical champions in their quest to change behavior at the bedside and secure budget allocation for the implementation of the brain pulse monitor at scale. We have built a competitive moat by two patent families that protect our proprietary sensor design. That design solves the key technical challenge of signal contamination from blood flow in the skin and enables us to one display a unique brain pulse to continuously report bilateral ICP and oxygen sets. Three, deliver one device that reports multiple parameters, and four provides clinicians confidence that the brain pulse monitor output correlates with the invasive gold standard. I'd like to invite you to invest in Simon as we build the next medtech Unicom based on Australian innovation and invention. Thank you